Brief Pain Inventory to Assess Cancer Pain and Quality of Life

Sponsor
Tata Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03546023
Collaborator
(none)
900
2
12
450
37.6

Study Details

Study Description

Brief Summary

Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their concentration and focus, and 67% excessive reliance on others. Only 34% reported a good quality of life. Effective pain management may help the patient to focus on the positive aspects of life, decreasing the focus on pain and also promote better adherence to reasonable treatment plans. Hence the emphasis is on improving the Quality of Life and not mere pain control.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient Interview

Detailed Description

This is a Prospective Observational Study. All new patients in chronic pain OPD are been administered BPI questionnaire as a standard of practice in our institute, in the language best understood by them e.g. English, Hindi, Marathi, Bengali. The participants will be asked to complete it once during their first visit to the pain clinic, before the start of treatment or ongoing treatment for pain (Baseline) and then during subsequent visits (Follow up). Most chronic pain patients are advised to follow-up by one to two weeks. Patients who are willing to participate in the study will be included after obtaining an informed consent. Data will be collected from BPI, Chronic Pain Record form and EMR and will be analyzed. Demographic data, diagnosis, pain data sheet, drug treatment as well as other form of therapies will be recorded. There will be no direct communication with the patient and data of quality of life will be retrieved from pain clinic records.

The Brief Pain Inventory (BPI) long form and short form questionnaire is a validated multidimensional pain assessment tool developed by Cleeland and Ryan. It is one of the most commonly used measures for assessing both pain severity and interference with functions in adults with cancer, thereby satisfying two recommendations (assessment of pain to include both intensity and interference) set by the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) group. It is brief, self administered, easily understood and can be administered to large numbers of patients,.

It contains three questions regarding pain intensity and seven regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain intensity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain. Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The sum of the scores of the pain intensity items represents the summed pain intensity score and the sum of the scores on the pain interference items represents the summed interference score. In addition, the patient enters his pain localization on a body drawing and can give details of his current medication.

Study Design

Study Type:
Observational
Actual Enrollment :
900 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Quality of Life in Patients With Chronic Cancer Pain Using Brief Pain Inventory. A Prospective Observational Study
Actual Study Start Date :
Jun 5, 2018
Actual Primary Completion Date :
Jun 4, 2019
Actual Study Completion Date :
Jun 4, 2019

Outcome Measures

Primary Outcome Measures

  1. Functional activity measurement using the Brief Pain Inventory (BPI) [followup visit (minimum 7 days)]

    Any change in baseline score of functional activity from BPI during the followup visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients registered in chronic pain OPD for 12 months from the date of approval of the study by IEC, at Tata Memorial Hospital.

  • Age ≥ 18 years

Exclusion Criteria:
  • Incomplete BPI forms.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tata Memorial Centre Mumbai Maharashtra India 400010
2 Tata Memorial Centre Mumbai Maharashtra India 400025

Sponsors and Collaborators

  • Tata Memorial Hospital

Investigators

  • Principal Investigator: Raghu Thota, MD, MNAMS, Tata Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raghu Thota, Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT03546023
Other Study ID Numbers:
  • 1921
First Posted:
Jun 6, 2018
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raghu Thota, Professor, Tata Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2019